Symphony IL-6 Cutoff Validation Study for Patients at Risk of Severe Sepsis

Status unconfirmed

Conditions studied: Severe Sepsis

In brief

Symphony IL-6 is a device that quantitates human IL-6 by fluorescence enzyme immunoassay (FEIA) from whole-blood specimens. Use of Symphony IL- 6 removes the need for plasma separation before testing. Symphony IL-6 comprises two components, the Symphony Fluorescence Immunoanalyzer and the Symphony IL-6 Cartridge. Whole blood is added to the cartridge and then up to six cartridges can be inserted into the immunoanalyzer. After 20 minutes a readout and printout are given with a quantitative IL-6 concentration. The used cartridges are fully enclosed and can be easily disposed of in general hospital bio-waste. Given the nature of this device and its portability, there is potential for future deployment as a point-of-care (POC) device. This study is to validate an interleukin-6 (IL-6) cutoff value using the Symphony IL-6 test for patients at high risk of severe sepsis caused by a COVID-19 infection

Key facts

Study ID: NCT05048927
Run by: Bluejay Diagnostics, Inc.
People needed: 48
Starts: 2021-08-31
Expected to finish: 2024-12-31
Last updated by the study team: 2023-08-14

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Whole blood specimen collected in EDTA anticoagulant tubes
Subject is considered to have severe or critical illness per below:
Severe Illness
SpO2 < 94% on room air at sea level;
Ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) < 300 mmHg;
Respiratory frequency > 30 breaths/min;
Or lung infiltrates >50% Critical Illness
a) Respiratory failure; b) Septic shock; c) And/or multiple organ dysfunction d) At least one criteria of severe illness
Subject confirmed to be COVID-19 positive by an EUA RT-PCR test
Subject is 18+ years of age
Minimum volume of 100µL for Symphony IL-6 testing
Specimen is available for testing within 12 hours from collection

You may not qualify if…

Subject is receiving an anti-IL-6 treatment
Subject is receiving corticosteroids
Hemolyzed specimens

Where it is running

Tina McCarthy — Acton, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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